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SOCRA CCRP Exam Syllabus Topics:

TopicDetails
Topic 1
  • Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.|Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.
Topic 2
  • Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.

Reference: https://www.socra.org/certification/ccrp-certification-exam/exam-overview/

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In recent years, some changes are taking place in this line about the new points are being constantly tested in the Certified Clinical Research Professional (CCRP) real exam. So our experts highlight the new type of questions and add updates into the practice materials, and look for shifts closely when they take place. As to the rapid changes happened in this exam, experts will fix them and we assure your CCRP exam simulation you are looking at now are the newest version. Materials trends are not always easy to forecast, but they have predictable pattern for them by ten-year experience who often accurately predict points of knowledge occurring in next CCRP preparation materials: Certified Clinical Research Professional (CCRP).

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